What is a Medical Device?
How Mexico's Reglamento de Insumos para la Salud defines a medical device, and which products fall under COFEPRIS jurisdiction.
What is Not a Medical Device?
Products that fall outside COFEPRIS medical device jurisdiction, including cosmetics, foods, medicines, and Annex 3 products.
Regulatory Framework Overview
The three-tier structure of Mexico's medical device regulatory system — Ley General de Salud, Reglamento de Insumos para la Salud, and the NOMs — and COFEPRIS's role within it.
Who Needs to Comply?
All parties in Mexico's medical device supply chain — domestic manufacturers, foreign manufacturers, Mexico Registration Holders, importers, and distributors — and their respective COFEPRIS obligations.
Lifecycle of a Medical Device in Mexico
The end-to-end regulatory journey of a medical device in Mexico — from classification and registration through to post-market surveillance, renewal, and deregistration.
DIGIPRiS — COFEPRIS Online Portal
Overview of DIGIPRiS, the COFEPRIS digital portal used for all medical device sanitary registration submissions, renewals, modifications, and import permits in Mexico.
Glossary of Key Terms
Key regulatory terms used in Mexico's medical device regulatory system, with Spanish originals and plain-English definitions.